Kit and method for quality control testing of an iontophoretic sampling system

• US 6,391,643 B1
• Filed: 10/27/1999
• Issued: 05/21/2002
• Est. Priority Date: 10/28/1998
• Status: Expired due to Term

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Liu, David M., Chen, Qiang, Wu, Christine M., Kersten, Brian S.
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US09/428,587
• Time in Patent Office: 937 Days
• Field of Search: 436/8, 436/14, 436/149, 436/150, 436/151, 422/61, 422/68.1, 422/82.01, 422/82.03, 702/19, 702/22, 702/23, 73/10.1, 73/10.2, 604/20, 600/345, 600/346, 600/347, 600/365, 607/115, 607/149
• US Class Current: 436/14
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control

Abstract

An automated system for continual transdermal extraction of analytes present in a biological system is described. The system optionally uses reverse iontophoresis to carry out the continual transdermal extraction of the analytes. The present invention describes quality control test kits, and methods of use thereof, for testing the ability of the system to provide reliable, effective, and accurate determination of analyte concentration.

Claims

1. A kit for testing the efficacy of a glucose monitoring system, said monitoring system comprising an iontophoretic sampling system and a sensor element wherein said iontophoretic sampling system comprises a first surface, said first surface comprising a reservoir, said reservoir comprising an ionically conductive medium and an enzyme capable of reacting with glucose to produce hydrogen peroxide, said kit comprising:

a cover having a shape that encloses said reservoir when said cover is placed in contact with said first surface of the iontophoretic sampling system said cover having a tops surface, retaining sides, and a bottom surface wherein (i) the bottom surface defines and opening, and (ii) when the bottom surface of the cover is in contact with the first surface of the iontophoretic sampling system, said first surface completes a bottom for said cover creating an enclosed space, and further wherein the top of said cover defines an opening through which a solution can be introduced into said enclosed space, and

a container holding a stable solution of glucose having a known concentration of glucose, wherein said glucose solution has a volume sufficient to at least cover said ionically conductive medium when it is introduced into said enclosed space.

2. The kit of claim 1, wherein said cover is formed from a material selected from the group consisting of polystyrene, polycarbonate, nylon, and polyester glycol.

3. The kit of claim 1, wherein said cover further defines a slit centrally located in the top of the cover.

4. The kit of claim 3, further comprising an adhesive strip effective to seal said opening and said slit.

5. The kit of claim 1, wherein said bottom surface of said cover is a flanged surface.

6. The kit of claim 1, wherein said bottom surface of said cover has an adhesive distributed thereon.

7. The kit of claim 1, further comprising instructions for use.

8. The kit of claim 1, wherein said glucose solution has a concentration of 100 μ

M.

9. The kit of claim 1, wherein said glucose solution further comprises a preservative.

10. The kit of claim 9, wherein said preservative is selected from the group consisting of sodium benzoate, methyl prophyl isoparaben, sodium azido, and sodium nipagin.

11. The kit of claim 10, wherein the preservative comprises sodium benzoate at 0.2% (w/w).

12. The kit of claim 1, wherein said container is a snap-top container.

13. A method of testing a glucose monitoring system to determine the sensitivity of the monitoring system relative to a known concentration of glucose in a glucose solution, said monitoring system comprising, an iontophoretic sampling system and a sensing element, said iontophoretic sampling system comprising a first surface, said first surface comprising a reservoir, said reservoir comprising an ionically conductive medium and an enzyme capable of reacting with glucose to produce hydrogen peroxide, said method comprising:

placing a cover in contact with said first surface of the iontophoretic sampling system, said cover having a top surface, retaining sides, and a bottom surface wherein (i) the bottom surface defines an opening, and (ii) when the bottom surface of the cover is in contact with the first surface of the iontophoretic sampling system, said first surface completes a bottom for said cover creating an enclosed space, and further wherein the top of said cover defines an opening through which a solution can be introduced into said enclosed space,

introducing a solution of glucose having a known concentration of glucose through said opening into said enclosed space, wherein said glucose solution has a volume sufficient to at least cover said ionically conductive medium; and

testing the glucose monitoring system'"'"'s sensitivity relative to the known concentration of glucose in the glucose solution.

14. A method of testing a glucose monitoring system'"'"'s ability to determine a known concentration of glucose in a glucose solution, said monitoring system comprising, an iontophoretic sampling system and a sensing element, said iontophoretic sampling system comprising a first surface, said first surface comprising a reservoir, said reservoir comprising and ionically conductive medium and an enzyme capable of reacting with glucose to produce hydrogen peroxide, said method comprising:

placing a cover in contact with said first surface of the iontophoretic sampling system, said cover having a top surface, retaining sides, and a bottom surface wherein (i) the bottom surface defines an opening, and (ii) when the bottom surface of the cover is in contact with the first surface of the iontophoretic sampling system, said first surface completes a bottom for said cover creating an enclosed space, and further wherein the top of said cover defines and opening through which a solution can be introduced into said enclosed space,

introducing a solution of glucose having a known concentration of glucose through said opening into said enclosed space, wherein said glucose solution has a volume sufficient to at least cover said ionically conductive medium; and

testing the glucose monitoring system'"'"'s ability to determine the known concentration of glucose in the glucose solution.

15. A method of testing monitoring system to determine that the glucose monitoring system can provide a predicable response to a known concentration of glucose in a glucose solution, said monitoring system comprising, an iontophoretic sampling system and a sensing element, said iontophoretic sampling system comprising a first surface, said first surface comprising a reservoir, said reservoir comprising an ionically conductive medium and a enzyme capable of reacting with glucose to produce hydrogen peroxide, said method comprising:

placing a cover in contact with said first surface of the iontophoretic sampling system, said cover having a top surface, retaining sides, and a bottom surfaces wherein (i) the bottom surface of the cover is in contact with the first surface of the iontophoretic sampling system, said first surface completes a bottom for said cover creating and enclosed space, and further wherein the top of said cover defines and opening through which a solution can be introduced into said enclosed space,

introducing a solution of glucose having a known concentration of glucose through said opening into said enclosed space, wherein said glucose solution has a volume sufficient to at least cover said ionically conductive medium; and

testing the glucose monitoring system'"'"'s ability to provide a predictable response to the known concentration of glucose in the glucose solution.